Bristol Myers Squibb’s Reblozyl (luspatercept-aamt) is approved as a first-line treatment for anemia in adults with lower-risk myelodysplastic syndromes.
Bristol Myers Squibb announced FDA approval of Reblozyl (luspatercept-aamt) as a first-line treatment for anemia without previous erythropoiesis stimulating agent use (ESA-naïve) on Aug. 28, 2023. The drug is indicated for adult patients with low-to-intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions.
According to a company press release, FDA approval was based on interim results from the Phase III COMMANDS trial. In the trial, 58.6% of patients treated with luspatercept-aamt achieved the primary endpoints of concurrent RBC transfusion independence of at least 12 weeks and mean hemoglobin increase of at least 1.5 grams per deciliter within the first 24 weeks. This was deemed to be superior efficacy to epoetin alfa, an ESA which had a 31.2% efficacy rate, regardless of ring sideroblast status.
“Today's expanded approval of [luspatercept-aamt] marks an important milestone in our commitment to MDS patients with anemia by providing a durable and more effective treatment option, with more convenient and less frequent administration,” said Wendy Short-Bartie, senior vice-president and general manager, U.S. Hematology and Cell Therapy, Bristol Myers Squibb, in the release. “We remain dedicated to addressing hard-to-treat diseases with significant burden to patients and look forward to bringing this important option earlier in the treatment process.”
“The majority of patients with MDS experience chronic anemia and require RBC transfusions,” said Tracey Iraca, executive director, MDS Foundation, in the release. “The approval of [luspatercept-aamt] in the first-line treatment of anemia for patients with lower-risk MDS represents a crucial step in making transfusion independence possible for more patients.”
Source: Bristol Myers Squibb
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.